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4-hydroxy-2-oxo-1-pyrrolidine acetamide freeze-dried preparation and its preparing method

A technology of pyrrolidine acetamide and freeze-dried preparations, which can be used in freeze-dried delivery, nervous system diseases, powder delivery, etc. It can solve the problems of not being able to meet market demand, take a long time, and only have capsules, etc., and achieve the benefit of large-scale Production, quick effect, strong effect

Inactive Publication Date: 2005-01-12
天津市资福医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the social demand for this drug is large, and the dosage form is single, only capsules, which cannot meet the market demand
And the capsules have the disadvantages of slow onset and long taking time, which are not suitable for emergency rescue

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0031] Take an appropriate amount of 4-hydroxy-2-oxo-1-pyrrolidine acetamide (Tianjin Zifu Pharmaceutical Co., Ltd.) and an appropriate amount of glycine (Beijing Jianli Pharmaceutical Co., Ltd.), add an appropriate amount of water for injection, stir to dissolve completely, and use phosphoric acid respectively. - Sodium dihydrogen phosphate buffer solution, NaOH solution to control the pH value of 4, 5.7, 5.7, 7.5, add water for injection to the full amount, and obtain 333 mg of 4-hydroxy-2-oxo-1-pyrrolidineacetamide per ml, glycine 70 mg solution. Add activated carbon according to the dosage of 0.05, 0.5, 1, and 2% (g / ml), respectively, stir at 20, 25, 30, and 40°C for 50, 30, 20, and 15 minutes, decarbonize and filter, and obtain the filtrate with 0.22μm Sterilization by microporous membrane fine filtration. Under aseptic conditions, the resulting solution is put in a sterile vial, put in a lyophilizer and freeze-dry according to the method of Example 8 for about 22, 25, 2...

Embodiment 5

[0033]Take an appropriate amount of 4-hydroxy-2-oxo-1-pyrrolidineacetamide, add an appropriate amount of water for injection, stir to dissolve it completely, the pH of the solution is about 7.0, and each ml contains 4-hydroxy-2-oxo- 1-pyrrolidineacetamide 150mg, 900mg solution. Add activated carbon according to the dosage of 1% (g / ml), stir at 30° C. for 30 minutes, decarbonize and filter, and the resulting filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, put the resulting solution in a sterile vial, freeze-dry it in a freeze dryer for about 25 hours, and then seal it aseptically to obtain the 4-hydroxyl-2-oxo-1-pyrrolidine of the present invention. Acetamide lyophilized powder preparations E, F.

Embodiment 6

[0035] Take an appropriate amount of 4-hydroxy-2-oxo-1-pyrrolidineacetamide and sorbitol, add an appropriate amount of water for injection, and stir to dissolve completely. Add NaH 2 PO 4 The pH value of the solution was adjusted to about 6.5 to obtain a solution containing 333 mg of 4-hydroxy-2-oxo-1-pyrrolidineacetamide and 80 mg of sorbitol per milliliter. Activated carbon was added according to the dosage of 2% (g / ml), stirred at 25° C. for 30 minutes, decarbonized and filtered, and the resulting filtrate was sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, the resulting solution is placed in a sterile vial, freeze-dried in a freeze dryer for 28 hours, and aseptically sealed to obtain 4-hydroxyl-2-oxo-1-pyrrolidineacetamide of the present invention Freeze-dried powder preparation G.

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PUM

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Abstract

The invention relates to a 4-hydroxy-2-oxo-1-pyrrolidine acetamide freeze-dried preparation and its preparing method, which is manufactured by freezing and drying a solution containing the 4-hydroxy-2-oxo-1-pyrrolidine acetamide or the 4-hydroxy-2-oxo-1-pyrrolidine acetamide and a pharmaceutically acceptable excipient; the pH value of said solution is between 4.5-7.5, preferredly in the scope of 4.5-6.5. Said excipient may be one or more than one materials chosen from glycine, lactose, sodium chloride, glucose and sorbitol. The solution may also contain a conventionally pharmaceutically acceptable assistant including stabilizer, analgesic, and buffer; a pharmaceutically acceptable pH regulator; and / or pharmaceutically acceptable medicines that have other secondary functions. The inventive freeze-dried preparation has a steady performance, a rapid effection, and a winne roler; it is easy to use, store and transport; and it is mainly used in the first aid of cerebral anoxic, which makes some serious patients get a prompt rescue.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a 4-hydroxy-2-oxo-1-pyrrolidineacetamide freeze-dried preparation and a preparation method thereof. technical background [0002] 4-Hydroxy-2-oxo-1-pyrrolidineacetamide (also known as Oxiracetam, Oxiracetam) is a new cyclic derivative of hydroxyaminobutyric acid (GABOB), which is a kind of Piracetam Nootropics. It has the effect of enhancing the vitality of semi-senescent cells and significantly improving brain memory, and is effective for senile memory and mental decline. It is clinically applicable to brain insufficiency, memory impairment, especially senile dementia, in addition, it is used for rehabilitation treatment of neurosis, traumatic brain injury, encephalitis and other diseases. In recent years, foreign researchers have discovered that 4-hydroxy-2-oxo-1-pyrrolidineacetamide and its similar drugs have anti-platelet aggregation and pharmacologica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61P25/00A61P25/28
Inventor 邵梅石秀伟
Owner 天津市资福医药科技开发有限公司
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